The Danger of Company Groupthink in FDA Advisory Committee Preparations

It might seem obvious that one person alone cannot drive successful FDA Advisory Committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.

Groupthink is a psychological phenomenon that occurs when a group is so focused on harmony or conformity that it sacrifices accurate analysis and critical thinking to “get along and go along.” The result – irrational or dysfunctional decisions.

We’ve all been to meetings dominated by one mindset or opinion, where if asked for feedback, the group serves up silence. This can result in stagnation – a meeting where nothing changes. Now imagine how groupthink can affect ADCOM preparations, which require critical analysis of data to create a credible and transparent story.

During preparations for ADCOM, the sponsor initially told us the product met its primary endpoint in two randomized clinical trials. But after reviewing the data, we discovered the endpoint was met ONLY when analyzing a subpopulation, not the prespecified intent-to-treat population. The team failed to see how this plan might irritate, even alienate the Advisory Committee. Groupthink clouded the minds of team members. If they had presented the data this way at ADCOM, without acknowledging the limitations, they would have lost credibility. Fortunately, they listened to 3D’s guidance, and changed their strategy.

Groupthink can occur in a company of any size, and if untamed, will silently impede progress and innovation – two things especially important when preparing for a high-stakes Advisory Committee meeting.

To ensure you’re leveraging the best thinking for your ADCOM preparations, anticipate and plan for company groupthink. Here are 5 steps to help you along the way:

  1. Build a critical thinking culture. Support and reward colleagues for objectively analyzing facts to form opinions. It’s okay to constructively critique process and strategy. Also, reward those who not only identify problems, but solve them. It’s easy to critique, more difficult to find solutions.
  2. Urge leaders to listen before they speak. Groups are swayed by shared information – especially when it comes from above. This can be useful when you want to get things done quickly, but stifling when you’re looking for ideas, creativity, or even objectivity. Leaders can do groups a service by emphasizing their desire to hear all points of view, including dissenting opinions, before sharing their own.
  3. Diversify your team. Actively include different types of people with various types of expertise. Unique backgrounds and experiences will naturally lend themselves to differing trains of thought.
  4. Incorporate technology to gauge group opinion. Technology is not only an effective way to capture data; it also allows people to cast silent opinions without fear of judgement or reprisal. Something as simple as conducting an electronic survey before or after a meeting can go a long way.
  5. Clearly set and respect roles within a group. A successful group is likely to get the information it needs simply because each member knows, in advance, that everyone gets a say. The group consists of people with clearly defined roles that are well understood by other group members.

Of course, at some point you must come to an agreement. Once you gather various points of view, then it’s time to land on a decision and move forward. Test that strategy and don’t reassess until after the test – otherwise you could go around and around in a circle of indecision. After the test, reassess. Get feedback. Revise.

One of the common reasons given for groupthink is “the absence of anticipating it.” So get in front of this psychological phenomenon. Encourage people from all levels and backgrounds to contribute – and welcome new strategies and new analyses.

For Advisory Committee success, “More minds are better than one.” But avoid groupthink.

The more diverse minds you have working on a problem, the more likely you are to arrive at a better solution. Remember:  If a thought is never heard, it has no chance of making an impact!

 

ABOUT THE AUTHOR

Catherine Carlisle Leonard uses her background as an academic writer, political speechwriter, lecturer, and researcher to identify, synthesize, and articulate important information from complex research. Catherine’s unique background allows her to translate information across various subject areas into concise verbal and visual presentations. In addition to her writing and research abilities, Catherine uses her excellent organizational and people skills to unite diverse teams and manage multi-faceted projects. Connect with Cat on LinkedIn.